Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET
|ClinicalTrials.gov Identifier: NCT01065818|
Recruitment Status : Terminated (Lack of funding)
First Posted : February 9, 2010
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer and lung cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are. For this study, a new type of solution, [F-18]-ﬂuoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment.
All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At each time of the PET/CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive ﬂuorine. 45-60 mines after the FLT injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Non-small Cell Lung Cancer||Drug: Fluoro-L-Thymidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Other Name: FLT
- Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response [ Time Frame: 2.5 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065818
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||K.S. Clifford Chao, MD||Columbia University|